Quality & Regulations

Clinical Research Quality Management System

The CRDO oversees and manages the Clinical Research Quality Management System (CRQM) to ensure regulatory and organisational compliance. The CRQM used is called Q-Pulse, and all policies, procedures and templates are held on the system, the system also manages training and distribution of documents to all research staff.

Risk Management

The CRDO oversees the process for the risk management of clinical trials and clinical investigations in the Saolta University Hospital Group (SUHG) and University of Galway, and supports the University and Saolta in formally identifying, assessing, managing, reporting, communicating risk.

Quality Assurance & Regulatory Affairs Function

The CRDO quality and regulatory roles oversee research which is undertaken by participating and accredited principal investigators according to local and national policies and consistent with the proposed research approvals. The CRDO oversees any external inspection or audit (e.g. Health Products Regulatory Authority (HPRA), sponsor) of research studies, as appropriate. In addition, the CRDO escalates issues relating to research conduct and integrity as they arise to ensure they are handled in line with institutional policies and procedures.